1.Application of graphene oxide in field of oral implant restoration
Chunrong SHI ; Jiaxu HE ; Lishan DENG ; Hailan WANG ; Aimin ZHAO ; Yiling YU ; Haixia GENG ; Weijun SONG
Chinese Journal of Tissue Engineering Research 2025;29(28):6118-6126
BACKGROUND:Graphene oxide,with its excellent physical and chemical properties and biocompatibility,can promote the differentiation of osteoblasts and inhibit the proliferation of bacteria,which will hopefully improve the success rate of implant restoration.OBJECTIVE:To summarize the research progress of graphene oxide in the field of dental implant restoration.METHODS:The related articles published by CNKI,WanFang Database,ScienceDirect,and PubMed from January 2000 to June 2024 were searched by computer.The keywords were"graphene oxide,dental implantation,biocompatibility,antibacterial mechanism,osteoblasts,mechanical properties,chemical properties"in Chinese and English.By reading the titles and abstracts,we preliminarily screened out the documents irrelevant to the topic of the article.According to the inclusion and exclusion criteria,65 documents were finally included for analysis.RESULTS AND CONCLUSION:Graphene oxide can increase the innate immune protection response of the body through its own antibacterial and drug-loaded antibacterial abilities,thus inhibiting the occurrence and development of periimplant inflammation.Graphene oxide can promote the proliferation and differentiation of bone marrow mesenchymal stem cells,enhance the proliferation of osteoblasts and vascular endothelial cells,inhibit the proliferation of osteoclasts,increase the rate of bone bonding between implants and alveolar bones,and contribute to the formation and stability of bone around implants.Graphene oxide can promote the combination of implant and gingival tissue,and reduce the occurrence of inflammation.Graphene oxide has low toxicity,and its biological safety needs further study.Graphene oxide coating endows the surface of titanium implant with excellent physical and chemical properties,which can greatly reduce the occurrence of complications such as implant fracture and prolong the survival time of implant.
2.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
Yiling FAN ; Ran ZHU ; Yan YANG ; Bo JIANG ; Minghui SONG ; Jing WANG ; Qiongqiong LI ; Gaomin LI ; Shujuan WANG ; Hong SHAO ; Shihong MA ; Xiaoyun CAO ; Changqin HU ; Shuangcheng MA ; Meicheng YANG ; Jun ZHANG
Drug Standards of China 2025;26(1):93-98
Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
3.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
4.Interpretation of"Guideline 9212 risk assessment and control of objectionable microorganisms for non-sterile products"in Chinese Pharmacopoeia 2025 Edition
Minghui SONG ; Ning ZHANG ; Qiongqiong LI ; Hong SHAO ; Yiling FAN ; Meicheng YANG ; Shihong MA ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):455-461
The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.
5.Interpretation of"Guideline 9110 for microbial whole genome sequencing technology"in Chinese Pharmacopoeia 2025 Edition
Minghui SONG ; Xin DOU ; Hong SHAO ; Yiling FAN ; Meicheng YANG ; Shihong MA ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):449-454
Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.
6.Association between gross motor development characteristics and child Chinese developmental dyslexia
Yuanchun REN ; Biyao FAN ; Yiling SONG ; Jiuju WANG ; Feilong ZHU ; Ning JI ; Qingjiu CAO
Chinese Mental Health Journal 2025;39(1):37-42
Objective:To explore the association between the gross motor development of children and Chi-nese developmental dyslexia.Methods:A total of 54 children were enrolled,indadit 27 children with Chinese DD and 27 age-gender-matched normal children.The Test of Gross Motor Development-Third Edition(TGMD-3),and the balance tests from the Movement Assessment Battery for Children(M-ABC)were used to evaluate the children's gross motor development level.Children's reading ability was evaluated by primary school students'literacy test question bank,one-minute reading task,and the Reading Test on Pupils.Results:The overall analysis of motortests showed that the grossmotor total score,locomotor score,object control score,and balance score in the DD group were significantly lower than those in the normal control group(P<0.05).Logistic regression analysis revealed a negative association between balance scores,locomotor scores,object control scores,TGMD-3 total scores and indi-viduals with dyslexia(OR=3.08,1.35,1.16,1.13,Ps<0.05).Conclusion:The delayed gross motor development of children is associated with the occurrence of Chinese developmental dyslexia.
7.Association between gross motor development characteristics and child Chinese developmental dyslexia
Yuanchun REN ; Biyao FAN ; Yiling SONG ; Jiuju WANG ; Feilong ZHU ; Ning JI ; Qingjiu CAO
Chinese Mental Health Journal 2025;39(1):37-42
Objective:To explore the association between the gross motor development of children and Chi-nese developmental dyslexia.Methods:A total of 54 children were enrolled,indadit 27 children with Chinese DD and 27 age-gender-matched normal children.The Test of Gross Motor Development-Third Edition(TGMD-3),and the balance tests from the Movement Assessment Battery for Children(M-ABC)were used to evaluate the children's gross motor development level.Children's reading ability was evaluated by primary school students'literacy test question bank,one-minute reading task,and the Reading Test on Pupils.Results:The overall analysis of motortests showed that the grossmotor total score,locomotor score,object control score,and balance score in the DD group were significantly lower than those in the normal control group(P<0.05).Logistic regression analysis revealed a negative association between balance scores,locomotor scores,object control scores,TGMD-3 total scores and indi-viduals with dyslexia(OR=3.08,1.35,1.16,1.13,Ps<0.05).Conclusion:The delayed gross motor development of children is associated with the occurrence of Chinese developmental dyslexia.
8.Application of graphene oxide in field of oral implant restoration
Chunrong SHI ; Jiaxu HE ; Lishan DENG ; Hailan WANG ; Aimin ZHAO ; Yiling YU ; Haixia GENG ; Weijun SONG
Chinese Journal of Tissue Engineering Research 2025;29(28):6118-6126
BACKGROUND:Graphene oxide,with its excellent physical and chemical properties and biocompatibility,can promote the differentiation of osteoblasts and inhibit the proliferation of bacteria,which will hopefully improve the success rate of implant restoration.OBJECTIVE:To summarize the research progress of graphene oxide in the field of dental implant restoration.METHODS:The related articles published by CNKI,WanFang Database,ScienceDirect,and PubMed from January 2000 to June 2024 were searched by computer.The keywords were"graphene oxide,dental implantation,biocompatibility,antibacterial mechanism,osteoblasts,mechanical properties,chemical properties"in Chinese and English.By reading the titles and abstracts,we preliminarily screened out the documents irrelevant to the topic of the article.According to the inclusion and exclusion criteria,65 documents were finally included for analysis.RESULTS AND CONCLUSION:Graphene oxide can increase the innate immune protection response of the body through its own antibacterial and drug-loaded antibacterial abilities,thus inhibiting the occurrence and development of periimplant inflammation.Graphene oxide can promote the proliferation and differentiation of bone marrow mesenchymal stem cells,enhance the proliferation of osteoblasts and vascular endothelial cells,inhibit the proliferation of osteoclasts,increase the rate of bone bonding between implants and alveolar bones,and contribute to the formation and stability of bone around implants.Graphene oxide can promote the combination of implant and gingival tissue,and reduce the occurrence of inflammation.Graphene oxide has low toxicity,and its biological safety needs further study.Graphene oxide coating endows the surface of titanium implant with excellent physical and chemical properties,which can greatly reduce the occurrence of complications such as implant fracture and prolong the survival time of implant.
9.Interpretation of"Guideline 9212 risk assessment and control of objectionable microorganisms for non-sterile products"in Chinese Pharmacopoeia 2025 Edition
Minghui SONG ; Ning ZHANG ; Qiongqiong LI ; Hong SHAO ; Yiling FAN ; Meicheng YANG ; Shihong MA ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):455-461
The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.
10.Interpretation of"Guideline 9110 for microbial whole genome sequencing technology"in Chinese Pharmacopoeia 2025 Edition
Minghui SONG ; Xin DOU ; Hong SHAO ; Yiling FAN ; Meicheng YANG ; Shihong MA ; Jun ZHANG ; Changqin HU
Drug Standards of China 2025;26(5):449-454
Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.

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